Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse (SCIMITAR)

Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse: the SCIMITAR Trial

This is a multicenter, observational prospective and retrospective study which aims are: 1) to compute a scoring model potentially predictive for the diagnosis of fibrosis by CMR in patients with MVP; 2) to identify specific features that may predispose to ≥ mild VAs or SCD in patients with MVP.

Study Overview

• Status: Recruiting
• Conditions: Mitral Valve Prolapse

Detailed Description

Patients with mitral valve prolapse and non-significant mitral regurgitation generally have a good prognosis. A minority of patients with MVP suffers from ventricular arrhythmias. Different demographic, clinical, and electrocardiographic characteristics, as well as morphological and structural features of the MV were described as potential risk factors for ventricular arrhythmias, among which fibrosis of the left ventricular inferolateral wall and posterior papillary muscle as detected by cardiac magnetic resonance.

As cardiac magnetic resonance has some limitations, it is unknown if and which patients with mitral valve prolapse should undergo cardiac magnetic resonance in routine clinical practice, to search for late gadolinium enhancement as a surrogate for myocardial fibrosis.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Gianluca Pontone, MD; Phone Number: +39 0258002574; Email: gianluca.pontone@cardiologicomonzino.it

Study Locations

• Italy
  • Milan
    • Milan, Milan, Italy, 20131
      • Recruiting
      • Centro Cardiologico Monzino
      • Contact: Chiara Centenaro; Phone Number: +39 0258002031; Email: chiara.centenaro@cardiologicomonzino.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of mitral valve prolapse by transthoracic echocardiography, independent of mitral regurgitation grade, either affected by Barlow's disease, fibroelastic deficiency, forme frustae of mitral valve prolapse.

Description

Inclusion Criteria:

• age ≥ 18 years
• Echocardiographic diagnosis of mitral valve prolaspe, defined as a systolic displacement of one or both mitral leaflets ≥ 2 mm above the plane of the mitral valve annulus in long-axis views

Exclusion Criteria:

• age< 18 years
• coexistence of other cardiomyopathies or other ≥ moderate valve diseases
• scarce acoustic transthoracic echocardiographic window
• usual contraindications for cardiac magnetic resonance

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Prospective Cohort; Prospectively enrolled patients will undergo a complete assessment, as clinically indicated, including clinical evaluation, TTE, rest ECG, 24h ECG-monitoring, and CMR. CMR will be performed no more than 6 months apart from other examinations (TTE, rest ECG, 24h ECG-monitoring).
Retrospective Cohort; Patients will be enrolled retrospectively, in case they have already performed all examinations between 2016 and 2023

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of fibrosis by CMR	Clinical, echocardiographic, electrocardiographic, and 24h-ECG monitoring variables will be collected in order to identify potential predictors of fibrosis as detected by cardiac magnetic resonance (CMR). Specifically, the following parameters will be collected.; Clinical data:; Transthoracic echocardiography parameters:; Rest ECG parameters:; 24h electrocardiographic monitoring parameters:; Ventricular arrhythmias (VAs) will be classified as suggested in the recently published EHRA consensus statement; CMR parameters, applying the protocol of the Society of Cardiovascular Magnetic Resonance	June 2026

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of ≥ mild Ventricular Arrhythmias and/or Sudden cardiac death in mitral valve	Clinical, echocardiographic, electrocardiographic, and CMR variables will be collected in order to identify potential predictors of ≥mild VAs, as defined by the recently published EHRA consensus document. An accurate description of these variables and the Units of Measure are the same as those reported in the section "Primary Outcome Measures".	June 2026
Clinical data	gender (female/male), and age in years;; family history for sudden cardiac death;; previous documentation of supraventricular and/or ventricular arrhythmias (VAs);; previous secondary prevention ICD implantation, previous transcatheter ablation of VAs;; symptoms (history of unexplained syncope/pre-syncope, palpitations, dyspnea, chest pain);; signs (mid-systolic click, murmurs of mitral regurgitation);; use of anti-arrhythmic drugs and/or beta-blockers.	June 2026
Transthoracic echocardiography parameters:	left atrial biplane volume in mL/m2;; presence, localization, and end-systolic measurement in millimeters of mitral annular disjunction (MAD);; mitral leaflet thickness in millimeters, presence of bileaflet prolapse;; mitral regurgitation (MR) grade, quantified by integrating qualitative and quantitative criteria according to the European guidelines;; left ventricular (LV) diameters in millimeters, volumes in mL/m2, and ejection fraction in %;; presence of curling of the posterolateral LV wall;; presence of the Pickelhaube sign at tissue Doppler imaging;; right ventricular end-diastolic area in cm2/m2, TAPSE in millimeters, and fractional area change in %;; systolic pulmonary artery pressure in mmHg, derived from the peak velocity of the tricuspid regurgitation and from the estimated right atrial pressure.	June 2026
Rest ECG parameters:	baseline rhythm (sinus rhythm, atrial fibrillation/flutter, junctional rhythm);; PQ and QRS intervals in milliseconds;; T wave inversion or biphasic T waves in the inferior and lateral leads;; QTc interval in milliseconds;; occurrence of premature supraventricular complexes;; occurrence of premature ventricular complexes (PVCs).	June 2026
24h electrocardiographic monitoring parameters:	baseline rhythm (sinus rhythm, atrial fibrillation/flutter, junctional rhythm);; frequency (expressed in absolute number and as percentage of total beats number), and repetitiveness of premature supraventricular complexes;; occurrence of atrial fibrillation;; frequency (expressed in absolute number and as percentage of total beats number), and repetitiveness of PVCs. Ventricular arrhythmias (VAs) will be classified as suggested in the recently published EHRA consensus statement: MILD VAs, defined as ≥ 5% total PVC burden or non-sustained (< 30 seconds) ventricular tachycardia (VT) runs with a heart rate < 120 bpm; MODERATE VAs, defined as non-sustained (< 30 seconds) VT runs with a heart rate of 120-179 bpm; SEVERE VAs, defined as non-sustained (< 30 seconds) VT runs with a heart rate > 180 bpm or sustained (≥ 30 seconds) VT/ventricular fibrillation.	June 2026
CMR parameters	MR grade (based on the regurgitant volume and regurgitant fraction);; LV mass in g/m2;; biventricular volumes in mL/m2, stroke volumes in mL, and ejection fraction in %;; presence of curling of the posterolateral LV wall;; presence, localization, end-systolic and end-diastolic measurement in millimeters of MAD;; presence and distribution of LGE.	June 2026

Collaborators and Investigators

• Sponsor: Centro Cardiologico Monzino
• Collaborators: Azienda Ulss 2 Marca Trevigiana; Humanitas Hospital, Italy; IRCCS Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Estimated): June 19, 2026
• Study Completion (Estimated): June 19, 2026

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Heart Valve Prolapse; Mitral Valve Prolapse
• Other Study ID Numbers: CCM1959

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No